Lipoic Acid Injectable Recalled for Sterility Concerns
The Compounding Shop is recalling Lipoic Acid 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility concerns in injectable products which pose a risk of serious injury.
Plain-English summary
The Compounding Shop, Inc. is recalling Lipoic Acid 25 mg/mL Injectable, 100 mL vials. The recall involves 55 vials distributed to locations in Florida, California, Minnesota, and Maine. All lots of the product are affected.
The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and a lack of assurance of sterility. The source text does not report any specific illnesses or injuries associated with the use of this product.
Consumers and healthcare providers who have this product should stop using it and contact The Compounding Shop, Inc. for further instructions or a return.
The recalled product
- Product
- Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 25 recalled by THE COMPOUNDING SHOP, INC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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